Nov 2, 2023 | FDA and USDA Regulatory Update
FDA has issued a Draft Guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities”. Comments may be made to Docket number FDA-2023-D-4416 by 26 December 2023. This draft guidance describes how the FDA will request and conduct...
Oct 19, 2023 | Cosmetics, FDA and USDA Regulatory Update
As the cosmetic facility registration and product listing requirement date approaches (29 December 2023), companies needing to register their facility, or list cosmetic products should be gathering the information required to submit to FDA. For facilities that need to...
Sep 28, 2023 | FDA and USDA Regulatory Update, Foods
On September 28, 2023, the U.S. Food and Drug Administration (FDA) has updated its Food Traceability Frequently Asked Questions (FAQ) to provide additional information about this rule. The Food Traceability Final Rule was published in November 2022 and requires the...
Sep 27, 2023 | FDA and USDA Regulatory Update, Uncategorized
On September 26, 2023, US FDA issued an updated Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. This new guidance material includes a new chapter specific to allergens. Key take-aways include: Establish and Implement a...
Sep 19, 2023 | FDA and USDA Regulatory Update
On Friday 15 September 2023, the FDA issued a draft guidance shedding light on the much-anticipated MoCRA registration and listing requirements. The guidance, titled “Registration and Listing of Cosmetic Product Facilities and Products” gives an overview of the...
Aug 29, 2023 | FDA and USDA Regulatory Update, Tobacco
On March 10, the U.S. Food and Drug Administration published a proposed rule titled, Requirements for Tobacco Product Manufacturing Practice. FDA is extending the proposed rule’s comment period by an additional 30 days to allow people additional time to submit...
